TNF blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents & Young Adults

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Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine:

Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young

Adults

AUDIENCE: Rheumatology, Gastroenterology, Oncology, Dermatology

ISSUE: FDA continues to receive reports of a rare cancer of white blood

cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in

adolescents and young adults being treated for Crohn's disease and

ulcerative colitis with medicines known as tumor necrosis factors (TNF)

blockers, as well as with azathioprine, and/or mercaptopurine. TNF blockers

include Remicade (infliximab), Enbrel (etancercept), Humira (adalimumab),

Cimzia (certolizumab pegol) and Simponi (golimumab).

BACKGROUND: HSTCL is an aggressive (fast-growing) cancer and is usually

fatal. The majority of cases reported were in patients being treated for

Crohn's disease or ulcerative colitis, but also included a patient being

treated for psoriasis and two patients being treated for rheumatoid

arthritis. FDA is now updating the number of reported cases of HSTCL.

Although most reported cases of HSTCL occurred in patients treated with a

combination of medicines known to suppress the immune system, including the

TNF blockers, azathioprine, and/or mercaptopurine, there have been cases

reported in patients receiving azathioprine or mercaptopurine alone.

RECOMMENDATIONS:

Educate patients and caregivers about the signs and symptoms of malignancies

such as HSTCL so that they are aware of and can seek evaluation and

treatment of any signs or symptoms.

These may include splenomegaly, hepatomegaly, abdominal pain, persistent

fever, night sweats, and weight loss.

Monitor for the emergence of malignancies when a patient has been treated

with TNF blockers, azathioprine, and/or mercaptopurine.

Know that people with rheumatoid arthritis, Crohn's disease, ankylosing

spondylitis, psoriatic arthritis and plaque psoriasis may be more likely to

develop lymphoma than the general U.S. population. Therefore, it may be

difficult to measure the added risk of TNF blockers, azathioprine, and/or

meracaptopurine.

Read the Drug Safety Communications for other specific recommendations for

Healthcare Professionals and Patients and the Data Summary for additional

information.

Healthcare professionals and patients are encouraged to report adverse

events or side effects related to the use of these products to the FDA's

MedWatch Safety Information and

Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by

fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA Drug Safety

Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedical\

Products/ucm251443.htm